Senior Quality Engineer

Hemanext, Inc.; Avon (MA); On-site; USD 120,000 - 165,000; Full time

Job summary

Hemanext, Inc. in Avon, MA is seeking a Sr. Quality Engineer to provide quality engineering support across operations, commercialization, and design and development of medical devices.

Strong cross-functional collaboration and project leadership are essential. Responsibilities include supplier management, NCR/CAPA handling, risk management, design control review, post-market surveillance, and ensuring compliance with ISO 13485 and 21 CFR.

Qualifications

• 10+ years hands-on experience with FDA QSR, ISO 13485 and MDD/MDR in a regulated medical device environment.
• Experience with design verification/validation and test methods for medical devices.
• Proficient in design controls and risk assessment techniques (FMEA, fault tree analysis, 5 Why's, Fishbone).

Responsibilities

• Support supplier management with supplier performance reviews, ASL updates, and SCARs.
• Review inspection records and process NCRs.
• Facilitate calibration of gages for calibration system.
• Manage risk management processes and post-market surveillance activities.
• Review design development and changes for justification, validation and verification updates, and risk assessments.
• Support product complaint investigations and rapid resolution of issues.
• Author CAPAs from internal or customer sources and KPI signals.
• Assist with Management Review compilations and presentations.
• Maintain compliance with ISO 13485, 21 CFR and other regulatory requirements.
• Maintain knowledge of government and industry quality assurance regulations across markets.

Skills

Communication skills

Quality systems knowledge

Project management

Documentation proficiency

Education

Bachelor's degree in science or engineering

Job description

The role of Sr. Quality Engineer has responsibility for providing quality engineering support in operations, commercialization, and design and development of medical device products. Excellent interpersonal and communication skills, as well as the ability to manage across functions, and multidisciplinary projects are key to be successful in this role.

KEY RESPONSIBILITIES

• Support the Supplier Management systems with supplier performance reviews, Approved Supplier List (ASL) updates, and SCARs as necessary.
• Support Operations Quality with review of inspection records and documenting and processing of NCRs.
• Facilitate Calibration of gages in support of the Calibration system.
• Manage the risk management process and post market surveillance/feedback review and updates.
• Review design development, and design change documents to ensure that all documentation includes the necessary justifications, validation and verification updates, risk assessment, etc.
• Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues;
• Author CAPAs when problems are detected through various channels, including customer complaints, internal sources, or KPls;
• Serve as a Deputy Management Representative.
• Assist with Management Review compilation and presentation
• Maintain compliance and continuously improve the Quality Management Systems in regard to ISO 13485, 21 CFR and other applicable regulatory requirements.
• Maintain a working knowledge or government and industry quality assurance regulations and standards for all markets where the product is distributed to.

REQUIREMENTS

Educational Requirements

• Bachelor's degree in science or engineering is preferred

Work Experiences:

• 10 years minimum hands-on working knowledge of the FDA QSR, ISO 13485 and MDD/MDR is required
• Experience with test methods and standards for the design, verification, and validation of medical device products.
• Experience in design controls, risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.

Specific Industry Experience:

• Experience in the FDA-regulated medical device industry is required
• Experience working in a highly regulated environment

Skills Requirements:

• Proficiency using the Microsoft Office Suite including Outlook, Excel, Word, PowerPoint, and Visio.